Follow up Study 5-6 Years After ILIT With 2 Concomitant Allergens, Birch and Grass

Allergic Rhinitis Clinical Trial

Official title:

Follow up Study 5-6 Years After ILIT With 2 Concomitant Allergens, Birch and Grass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04296474
• Other study ID #: Follow-up ILIT 2018/2645-32
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 15, 2018
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

52 patients that had previously participated in the RDBPC study of intralymphatic immunotherapy (ILIT) with 2 concomitant allergens, birch and grass, with NCT02423707, were eligible for an open follow up 5-6 years after treatment.

Description:

Bakground: Intralymphatic immunotherapy has been proposed as a new, more effective, modality for allergy immunotherapy. With ultrasound- guided injections into the lymph node the allergen is injected directly to the secondary lymphoid organ to stimulate the immune system. The protocol that has been used so far is three injections with one month interval. The effect have been evaluated in several studies with limited sample sized and the effect have been estimated to be in the same range as after conventinal subcutaneous immunotherapy. No long term follow up have been performed. Objective: To investigate if the clinical improvement and immunological alterations is maintained 5-6 years after ILIT with two concomitant allergens, birch and grass. Methods: 52 patients that had previously participated in the RDBPC study were asked to participate in this open follow up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 1, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Moderate to severe allergic rhinitis to birch and grass pollen defined with a positive skin prick test and elevated allergen specific IgE antibodies

Exclusion Criteria:

• uncontrolled or perennial asthma
• other pulmonary disease
• known autoimmune or collagen disease
• chronic infection
• other significant disease
• severe atopic dermatitis
• use of beta blockers or angiotensin converting enzyme inhibitors as antihypertensive medications
• symptomatic sensitization to house dust mite or furry animals with daily exposure
• chronic upper airways disease
• pregnancy
• nursing
• obesity with BMI >30
• withdrawn informed consent

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• ALK Alutard 5-grasses and birch
Intralymphatic injections
• ALK Diluent
intralymphatic injections

Locations

Country	Name	City	State
Sweden	Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Lund	Lund
Sweden	Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Malmö	Malmö
Sweden	ENT department, Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Lars Olaf Cardell

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Hellkvist L, Hjalmarsson E, Kumlien Georén S, Karlsson A, Lundkvist K, Winqvist O, Westin U, Cardell LO. Intralymphatic immunotherapy with 2 concomitant allergens, birch and grass: A randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2018 Oct;142(4):1338-1341.e9. doi: 10.1016/j.jaci.2018.05.030. Epub 2018 Jun 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal grass allergen provocation	The symptoms are recorded during 30 minutes after nasal spray with grass allergen	5-6 years after active or placebo ILIT
Secondary	Nasal birch allergen provocation	The symptoms are recorded during 30 minutes after nasal spray with grass allergen	5-6 years after active or placebo ILIT
Secondary	Combined symptoms and medciations score	Ranging from 0- no symptoms and medication, to 6- maximum symptoms and medication.	Pollen season 5-7 years after active or placebo ILIT
Secondary	Rhinoconjunctivitis quality of life questionnaire	Average score of 28 questions ranging from 0-no impairment of quality of life, to 6- maximum impairment of quality of life.	Pollen season 5-7 years after active or placebo ILIT
Secondary	Sinonasal outcome test quality of life questionnaire	Sum of 22 questions. The score ranges from 0-no impairment of quality of life, to 110- maximum impairment of quality of life.	Pollen season 5-7 years after active or placebo ILIT
Secondary	Allergen specific IgE	Blood test	5-6 years after active or placebo ILIT
Secondary	Allergen specific IgG4	Blood test	5-6 years after active or placebo ILIT
Secondary	T-cell and basophil activation	Blood samples and lymph node aspirates are investigated with flow cytometry	5-6 years after active or placebo ILIT